Effect of Home-based High-Intensity Interval Training Using TeleRehabilitation Among Coronary Heart Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Cardiorepisratory fitness (CRF)
研究概览
简要总结
Telerehabilitation has the potential to become an alternative attitude to outpatient cardiac rehabilitation. The aim of our study is to research the method of high-intensity interval training in the home environment using telerehabilitation. Investigators assume that the high-intensity interval training form of telerehabilitation, using a heart rate monitor as a tool for backing up training data, can improve physical fitness and lead to higher peak oxygen uptake as the traditional moderate-intensity continuous training. The study is designed as a monocentral randomized controlled trial at University Hospital Brno in the Czech Republic.
After the coronary event, eligible patients will be randomly (in 1:1 ratio) separated into two groups: the experimental high-intensity interval training group and the moderate-intensity continuous control group. Both groups undergo a 12-week telerehabilitation training program with a 52-week follow-up period. The primary outcome observed will be the effect of intervention expressed by changes in peak oxygen uptake values.
详细描述
The study relates to the previous study project CR-GPS, in which investigators proved the feasibility of cardiac telerehabilitation. The results showed that aerobic capacity and quality of life improved similarly in telerehabilitation and outpatient group of participating patients. During the research, investigators used the moderate-intensity continuous method. The present research focuses on high-intensity interval training, which presents comparable or even better results in cardiorespiratory condition effects and requires less time than a continuous method in patients with low or medium cardiovascular risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with coronary artery disease (in last two months)
- •with low or medium cardiovascular risk
- •with heart revascularization
- •with recommended pharmacotherapy
- •with clinically stable state
- •with the ability to perform a cardiopulmonary exercise test
- •with the ability to understand and write in the Czech language
- •with an internet connection at home
- •literacy with information and communication technology
排除标准
- •Participants who were hospitalized with heart disease in the previous six weeks
- •with psychological severe or cognitive disorders
- •with contraindications for cardiopulmonary exercise testing
- •with severe training limitations besides coronary artery disease
- •with a planned intervention or operation
- •participants who are enrolled in or participate in an outpatient form of cardiac rehabilitation
- •participants who plan to be or are included in other studies
结局指标
主要结局
Cardiorepisratory fitness (CRF)
时间窗: Change from baseline to 12 weeks and 52weeks
Peak oxygen uptake (VO2peak) during cardiopulmonary exercise test
次要结局
- Training adherence (Number of compliant participants, Average exercise time, Overall completition rate)(12 weeks)
- Anxiety (General anxiety disorder, 7-item scale)(Change from baseline to 12 weeks and 52weeks)
- Incidence of treatment-emergent adverse events assessed by 5 grade scale(Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks.)
- Health-related quality of life (SF-36 Form)(Change from baseline to 12 weeks and 52weeks)
- Hospital Anxiety and Depression scale (HADS)(Change from baseline to 12 weeks and 52weeks)
- Body composition (BIA)(Change from baseline to 12 weeks and 52weeks)
- Satisfaction - self-completed questionnaire(12 weeks and 52weeks)
研究者
Ladislav Batalik
Principal Investigator
Brno University Hospital